TRANSLATION SERVICES

We provide compliance consultation and guidance for organizations in the pharmaceutical, biotech and medical device industries. In all GxP engagements, we strive for immediate and sustained process improvement, from product development to patient delivery.

We combine our strategic consulting experience in regulatory compliance with our instructional design and training development capabilities to bring you the right resources to address your compliance challenge, distribute information to the people that need it, and sustain the gains you've achieved. We'll assess your unique challenges, develop a plan of action informed by Quality by Design principles, and build a Knowledge Base of training and documentation for sustained compliance.

GCP Audits and ConsultingDepend on our clinical regulatory expertise

Whether you need assistance with Clinical Operations, Regulatory Affairs, Clinical Development, Quality Systems or Vendor Assessments, we're ready to partner with you to support patient safety through expert guidance, data integrity and professional communication.

GMP ConsultingGMP with a Quality by Design approach

The principles of Quality by Design are infused in all our activities, whether the engagement involves commissioning of a new facility, auditing for inspection readiness, or managing for remediation. Whatever the situation, we provide thorough analysis and assessment to develop an action plan, with strategies and tactics for Compliance Sustainability.

Patient safety depends on effective communication with a variety of audiences: consumers, employees, vendors, company leadership and regulatory agencies. We meld together scientific and business-process knowledge with world-class instructional design to establish and sustain auditable processes, ensuring your products are the best they can be. Our training and communications solutions range from live training and eLearning to technical writing and knowledge base development.

Technically accurate translations are absolutely critical in regulated industries. We provide in-country language currency to ensure local and harmonized compliance. Our translators have work experience in the respective discipline so they’re familiar with technical terms and concepts specific to the subject matter. Through validation and back translations, our translated content is verified by more than one expert linguist, so you can rely on its technical accuracy.

LearnLink™LearnLink™ is an online learning and content delivery system

Looking for an economical way to host your eLearning courses or sales materials? Need a secure way to share files with employees and clients? Check out LearnLink™, our proprietary cloud-based hosting and file storage portal.